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Tag No.: C0812
Based on interview, policy review, and review of the admission agreement, the provider failed to inform twenty-five of twenty-five sampled inpatients and outpatients (1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, and 25) a physician had not been on-site 24 hours per day/seven days a week (24/7). Findings include:
1. Review of sampled inpatients and outpatients (1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, and 25) revealed there had been no documentation acknowledging they had been informed the physician was not available onsite twenty-four hours a day, seven days a week.
Interview on 8/17/22 at 9:00 a.m. with registered nurse (RN) D regarding patient record reviews revealed:
*They had not been providing patients with information that a physician is not on-site 24/7.
-She stated someone from Sioux Falls informed her they no longer needed to provide patients with that information.
-She was unable to give more information as to who informed her of this or why.
*There was a sign at the nurses' station which stated they did not always have a physician on-site.
-She agreed not all patients would see the sign at the nurses' station.
Review of the provider's Nursing Care Admission Agreement revealed the form had not informed the patient that a physician would not be on-site twenty-four hours per day, seven days a week in the facility.
Interview on 8/17/22 at 10:40 a.m. with clinical quality specialist (CQS) C and health information management (HIM) technician G revealed:
*Surveyor inquired when their process had changed regarding informing patients of physician availability.
-CQS C had asked HIM technician G when the process had changed.
-HIM technician G was unsure as all of the company's other critical access hospitals do this procedure.
*CQS C or HIM technician G was unsure why they had not been following this process.
Review of the provider's August 2022 Hospital and ED [emergency department] Coverage and Notification of On-Call Provider policy revealed, "Providers are not present 24 hours a day, 7 days a week..."
Interview on 8/17/22 at 1:15 p.m. with CQS C, director of nursing and clinical services B, and RN D revealed they:
*Had been unaware of what the requirement was regarding lack of physician availability.
*Were provided education to the patient regarding lack of physician availability.
*Had not been receiving a signed acknowledgment from the patient that they had been aware of the lack of physician availability in the building.
*Did not have any additional policies to address further documentation of physician availability.
*Agreed physicians were not available in the building twenty-four hours a day, seven days a week.
Tag No.: C1016
Based on observation, interview, record review, and policy review, the provider failed to ensure:
*Medications at risk for diversion had been properly secured and monitored to prevent unauthorized access in:
-One of one procedure room.
-One of one maintenance closet.
Findings include:
1. Observation on 8/17/22 at 11:50 a.m. in the provider's procedure room revealed:
*There was a black sharps container located on the countertop.
*Half of the covered top was open.
*Inside the black container was multiple vials of medication labeled as propofol and contained a white milky substance inside the vials.
*The container was almost full and appeared to have 40 to 60 vials of unsecured propofol.
Phone interview on 8/17/22 at 1:41 p.m. with the pharmacist F regarding the medications found in the procedure room revealed:
*The staff performing the sedation, discarded the vials of propofol into the black sharps container.
*Once the container is full, maintenance staff came up and removed the sharps containers.
*The sharps containers are brought down to the maintenance room until they are picked up.
*He:
-Had not been aware the lid was open on the sharps container.
-Had expected the sharps container to be secured.
-Agreed no one would be aware if vials had been removed from the container.
-Had not believed the containers could be opened up after they were closed.
Observation and interview on 8/17/22 at 2:00 p.m. with clinical quality specialist (CQS) C in the procedure room revealed:
*She agreed the vials in the sharps containers were vials of propofol.
-She agreed there was medication remaining inside the vials.
*No one was counting the medications discarded in the vials or sharps container.
*Propofol could have been diverted.
*Nursing aides cleaned the procedure room.
*She had not been aware that maintenance and housekeeping had access to the procedure room.
Observation and interview on 8/17/22 at 2:15 p.m. with assistant maintenance mechanic (AMM) (E) of the maintenance shop where the sharps containers had been stored revealed:
*The maintenance shop door was unlocked.
*He reached inside his unlocked drawer was a key for a closet.
*Inside the locked closet:
-Were approximately 15 sharps containers of various sizes.
-Sharps container that this surveyor was able to open revealed multiple prescription bottles full of patients' medications, with their names on the labels.
-The last time the sharps containers had been picked up to be destroyed was three years ago.
*He had access to the procedure room.
Interview on 8/17/22 at 3:00 p.m. with RN D regarding the unsecured propofol in the procedure room revealed:
*She would go to the pharmacy and bring the propofol into the procedure room.
*The unused propofol was discarded into the black sharps container.
*When the black sharps box was full, she closed the lid so it would be locked, and then took the black sharps container to the locked closet located in the maintenance department.
*She agreed the unused propofol was not secured in the procedure room.
*She had not been aware there was a full sharps container of vials and syringes in the procedure room.
Interview on 8/17/22 at 3:05 p.m. with pharmacist F regarding the propofol in the procedure room revealed they did not have a policy or procedure for the wasting of unused propofol.
Review of the provider's February 2022 Medication, Controlled Drug Disposition policy revealed, "To assure all drugs are properly accounted for and recorded."